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Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)

E

Elsan

Status

Enrolling

Conditions

MRI
Tattoo Disorder

Treatments

Procedure: MRI
Other: Likert scale questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT05691634
2021-A02758-33

Details and patient eligibility

About

MRI examinations are potential sources of complications related to the displacement of ferromagnetic objects, but also to heating effects that can go as far as burns. This overheating can be caused by contact with external equipment (sensors, cables, etc.). Patients with skin tattoos may experience specific complications as tingling or "burning" felt at the site of the tattoo. They can be followed by a transient erythema with edema around the reversible tattoo in 12 and 72 hours. One observation of severe 2nd degree burns has been reported. They would be linked to the presence of metallic salts in the dermis, resulting from interactions between the pigments and the magnetic field but their mechanisms are poorly identified and divergent.

The aim of this study is to assess the rate of MRI causing complications in patients with tattoos.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Major patient
  • tattoo patient
  • Ability to answer the questionnaire
  • Affiliated patient or beneficiary of a social security scheme
  • Patient having been informed and not objecting to the research

Exclusion criteria

  • Minor
  • Patient unable to understand and respond to questionnaires due to language difficulties or cognitive impairment
  • Patient objecting to research
  • Pregnant or breastfeeding woman
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3,000 participants in 1 patient group

Patient with tatoo
Experimental group
Treatment:
Other: Likert scale questionnaire
Procedure: MRI

Trial contacts and locations

1

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Central trial contact

Christine Bagard; Duband Sandrine

Data sourced from clinicaltrials.gov

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